MDR challenges – a manufacturer’s perspective
10:45 AM - 11:25 AM
Manufacturers have been working for many years on implementing the MDR requirements and on converting MDD compliant products to MDR compliant. From the beginning, this endeavour posed many challenges, not only based on the uncertainty we started off with, but also based on the capacity of Notified Bodies, challenges in interpretations, and for many of us, simply the magnitude of the work ahead. This is a recap of where we came from, what is today’s status and what is ahead of us. Now that MDR implementation is complete, sustaining the MDR compliance is the new challenge ahead which requires our full attention.